White crystalline powder, hygroscopic, soluble in water. Used as a contraceptive (uterotonic) Appearance White or almost white powder Dissolubility Very soluble in water. It dissolves in diluteSolutions of acetic acid and of ethanol (96%) HPLC Retention time conforms to that of reference Ph 3.0-6.0 Water (KF) ≤5.0% Related substances(by HPLC) Individual ≤1.5%Together ≤5.0% Amino acids Asp 0.90~1.10Glu 0.90~1.10Pro 0.90~1.10Gly 0.90~1.10Leu 0.90~1.10Ile 0.90~1.10Tyr 0.70~1.05Half-Cys 1.40~2.10 Acetic acid (by HPLC) 6%-10% Bacterial endotoxin <300 IU/mg Total bacterial count ≤100 CFU/g Assay (by HPLC) 93.0%~102.0% Activity Potency≥480 IU/mg Conclusion It conforms to EP 8.0 and USP 37. Storage Protection to light, at a temperature of 2 °C to 8 °C. Package: 10G/bag; 1KG/bag . Storage: Protection to light, at a temperature of 2 °C to 8 °C. Avoid to moisture.
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